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Completed

NCT Number: NCT01842230

Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine

The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic properties of Telmisartan/S-amlodipine

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 20 aged and 45 aged in healthy male and female
  • Body weight more than 55kg in male, 50kg in female
  • Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2) 4.If female, must include more than one among the items
  • The menopause (there is no natural menses for at least 2 years)
  • Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
  • The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject.
  • you are using one of the following contraceptive measure for 3 months before screening, and Necessarily you agree that used continuously contraceptive measure during the clinical trial and for 1 month after the final dosing investigational product.(But, should not use a device of contraception or oral contraceptive drug that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium drug interactions during the clinical trials)
  • Abstinence.
  • Physical interrupt method (such as a condom, contraceptive diaphoretic or cervical cap)
  • In case of women of childbearing age, the serum β-hCG pregnancy test is negative, and urine β-hCG test is negative before taking the investigational product.

5.If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms during clinical trials and do not sperm donation during clinical trials and until one month after the final dosage of investigational products 6.Those who fully understand about this clinical trial after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent.

Exclusion criteria

  • Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system (heart failure, etc.).or mental illness, or a history of mental disease.
  • Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)
  • hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin calcium) or additives.
  • An impossible one who participates in clinical trial including screening tests(medical history taking, BP, physical examination, 12-lead ECG, blood & urine laboratory test result) before 28 days the taking Investigational Products.
  • Defined by the following laboratory parameters:
  • AST, ALT> 1.25* upper limit of normal range
  • Total bilirubin > 1.5* upper limit of normal range
  • CPK > 1.5* upper limit of normal range
  • eGFR(using by MDRD method) < 60 mL/min/1.73m2
  • Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after 5minuts break.
  • Drug abuse or have a history of drug abuse showed a positive for urine drug test.
  • Pregnant or lactating women.
  • A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes/day)
  • Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of the subjects.
  • Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
  • Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
  • Subject who treated with any investigational drugs within 60days before the beginning of study treatment (However, biologicals applies for 90 days, but can be based on a more extended period of time by considering the half-life)
  • Previously donate whole blood within 60 days or component blood within 30days.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • Positive for Serology test(Hepatitis B, Hepatitis C, HIV).

Treatment and study plan

Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg

Drug
  • Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
  • Atorvastatin 40mg: 1 tablet, oral, once daily, 2days
  • over the period I & II(cross-over)

Telmisartan 80mg and S-amlodipine 5mg

Drug
  • Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
  • over the period I & II(cross-over)

Primary outcomes

  1. In the steady state Telmisartan 80mg and S-amlodipine 5mg AUClast

    Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose

    AUClast = Area under the plasma concentration-time curve from zero time until the last measurable concentration

  2. In the steady state Telmisartan 80mg and S-amlodipine 5mg Cmax

    Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine: Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose

    Cmax=Maximum Plasma Drug Concentration

Secondary outcomes

  1. In the steady state Telmisartan 80mg & S-amlodipine 5mg AUCinf

    Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose

    AUCinf=Area under the plasma concentration-time curve from time zero to infinity

  2. In the steady state Telmisartan 80mg & S-amlodipine 5mg Tmax

    Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose

    Tmax=Time to Cmax

  3. In the steady state Telmisartan 80mg & S-amlodipine 5mg T1/2

    Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose

    T1/2=Observed terminal elimination half-life

  4. Number of Participants with Adverse Events

    Time frame: From 1day to 22 days

    • Evaluated safety parameters included: Physical examination, vital sign, Laboratory test, ECG
    • Adverse event monitoring

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine After Oral Administration in Healthy Volunteers

Acronym: CKD-345 DDI

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2013
Registry last updated
Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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